Neoadjuvant treatment for MSS colon cancer using Tislelizumab and chemotherapy

Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer (NETSAC): A Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study

This study is testing if combining a new immune treatment called Tislelizumab with chemotherapy can help people with advanced colon cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Guangxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT06124378 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combining Tislelizumab, an immune checkpoint inhibitor, with chemotherapy in patients with locally advanced microsatellite stable (MSS) colon cancer. Participants will receive 2 to 4 cycles of Tislelizumab along with Oxaliplatin and Capecitabine before undergoing complete mesocolic excision surgery. The primary goal is to assess the proportion of patients achieving a pathological complete response (pCR) in their surgically resected tumors. This approach aims to enhance tumor remission and potentially improve long-term survival outcomes for patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed MSS colon adenocarcinoma and specific tumor staging criteria.

Not a fit: Patients with distant metastasis, multiple primary tumors, or those who have received prior anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved survival rates and reduced recurrence of colon cancer in patients with MSS tumors.

How similar studies have performed: While previous studies have explored neoadjuvant therapies for colon cancer, the combination of Tislelizumab with chemotherapy in MSS colon cancer represents a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old and ≤75 years old.
* Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.
* The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.
* Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis.
* The Eastern Cooperative Oncology Group physical status score is 0-1.
* Life expectancy is expected to be more than 1 year.
* First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.
* Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g/L, Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 75×10\^9/L, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL, Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.
* Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.

Exclusion Criteria:

* Enhanced CT stage (T1-3N0M0)
* Multifocal colorectal cancer.
* CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.
* Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement.
* Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.
* History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
* Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), American Society of Anesthesiologists score \> 3 points.
* Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.
* Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.
* Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.
* Unable to undergo enhanced CT examination
* Pregnancy or lactation.
* Refused to participate in this study.
* Other situations in which the researcher deems unsuitable for this study.

Where this trial is running

Nanning, Guangxi

• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)

Study contacts

• Study coordinator: Minglin Lin

Conditions Colonic Neoplasms; Neoadjuvant Therapy; Immune Checkpoint Inhibitors; Colon cancer, Neoadjuvant chemotherapy; PD-1 inhibitor